Metabolic Change in Prostate Cancer Bone Metastases on 68Ga-HBED-CC-PSMA PET/CT Following Radium-223 Therapy

Sir Mortimer B. Davis - Jewish General Hospital14 enrolled

Overview

Broadly, the objective of this study is to evaluate the fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT in bone metastases from prostate cancer following treatment with radium-223 as a surrogate marker for tumor cell killing.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

radium-223 dichlorideDRUG

6 doses of Radium-223

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria * Resident of Canada * Male sex * Age 18 years or older * Progressive (symptoms, conventional imaging, PSA, bone scan, FCH PET/CT or other) castration-resistant prostate cancer in the judgment of the treating physician without change in systemic anti-neoplastic therapy since documented progression * Six or greater bone metastases robustly-avid on recent (4 weeks) MDP or NaF scintigraphy * Recently failed (within 3 months) or failing novel androgen receptor pathway inhibitors (abiraterone + prednisone or enzalutamide) with intention of continuing the drug for at least 7 months OR minimum 14 day washout period from either agent prior to study enrollment * No known visceral metastases or adenopathy greater than 3 cm short axis on conventional imaging * Not received docetaxel for castration-resistant disease * ECOG performance status 0 - 2, inclusive * Life expectancy of greater than 6 months * Serum testosterone less than or equal to 50 ng/dl * Hemoglobin greater than or equal to 100 g/L with no blood transfusions or EPO in preceding 3 weeks * Neutrophils greater than or equal to 1.5 x109/L * Platelets greater than or equal to 100 x109/L * No prior hemi-body radiotherapy * No impending or established spinal cord compression * No unmanageable fecal incontinence * Patient has good IV access * Able to understand and provide written informed consent Exclusion Criteria * Planned change in systemic anti-neoplastic therapy during the approximately 7 month trial * Unable to tolerate the physical/logistical requirements of a PET/CT scan including lying supine for up to 30 minutes with the arms above the head and tolerating intravenous cannulation for injection of the study drug. * Medically unstable patients (e.g. acute cardiac or respiratory distress or hypotensive, etc.) * Patients who exceed the safe weight limit of the PET/CT bed (approximately 400 lbs.) or who cannot fit through the PET/CT bore (70 cm diameter) * Patients who are claustrophobic

Locations (1)

Jewish General Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

SUV-max

fractional decline of intensity of tracer uptake measured by SUVmax on 68Ga-PSMA PET/CT

Time frame: 6 months

Data from ClinicalTrials.gov

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